Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoffmann-La Roche, Inc. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
71 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | Hoffmann-La Roche, Inc. | 1985-06-25 | 123 | 0 |
| K831694 | RENAK | Hoffmann-La Roche, Inc. | 1983-07-19 | 56 | 0 |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Hoffmann-La Roche, Inc. | 1983-03-10 | 23 | 0 |
| K823573 | COBAS REAGENT FOR CREATININE | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823580 | COBAS REAGENT FOR INORGANIC PHOSPHORUS | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823574 | COBAS REAGENT FOR ALBUMIN | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823575 | COBAS STANDARDS FOR ALBUMIN | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823576 | COBAS STANDARD FOR TOTAL PROTEIN | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823572 | COBAS STANDARDS FOR CREATININE | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823577 | COBAS REAGENT FOR CALCIUM | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Hoffmann-La Roche, Inc. | 1983-01-07 | 32 | 0 |
| K822219 | HUMAN PLASMA CONTROL FOR CEA-ROCHE | Hoffmann-La Roche, Inc. | 1982-12-28 | 155 | 0 |
| K823212 | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE | Hoffmann-La Roche, Inc. | 1982-11-29 | 32 | 0 |
| K820942 | ROCHE(R) B-HCG RIA URINE STANDARD | Hoffmann-La Roche, Inc. | 1982-05-03 | 27 | 0 |
| K820614 | ROCHE B-HCG STANDARDS | Hoffmann-La Roche, Inc. | 1982-04-01 | 24 | 0 |
| K820613 | ROCHE B-HCG RIA | Hoffmann-La Roche, Inc. | 1982-04-01 | 24 | 0 |
| K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | Hoffmann-La Roche, Inc. | 1982-03-08 | 26 | 0 |
| K812986 | AGGLUTEX AMPHETAMINE TEST KIT | Hoffmann-La Roche, Inc. | 1982-01-22 | 88 | 0 |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | 66 | 0 |
| K812985 | AGGLUTEX MORPHINE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | 66 | 0 |
| K812987 | AGGLUTEX METHAQUALONE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-22 | 57 | 0 |
| K812730 | SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE | Hoffmann-La Roche, Inc. | 1981-10-23 | 25 | 0 |
| K812732 | SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE | Hoffmann-La Roche, Inc. | 1981-10-19 | 21 | 0 |
| K812729 | SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE | Hoffmann-La Roche, Inc. | 1981-10-19 | 21 | 0 |
| K812731 | SEPTI-CHECK BLOOD CULTURE SLIDE | Hoffmann-La Roche, Inc. | 1981-10-19 | 21 | 0 |
| K811116 | HCG RADIOIMMUNOASSAY | Hoffmann-La Roche, Inc. | 1981-05-13 | 19 | 0 |
| K810905 | ISOMUNE-CK | Hoffmann-La Roche, Inc. | 1981-04-14 | 11 | 0 |
| K801244 | ROCHE HCG STANDARDS | Hoffmann-La Roche, Inc. | 1980-06-20 | 24 | 0 |
| K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO | Hoffmann-La Roche, Inc. | 1980-01-17 | 22 | 0 |
| K792671 | COBAS-BIO CENTRIFUGAL ANALYZER | Hoffmann-La Roche, Inc. | 1980-01-17 | 21 | 0 |
| K792657 | SENSI-SLIDE | Hoffmann-La Roche, Inc. | 1980-01-16 | 21 | 0 |
| K791373 | ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS | Hoffmann-La Roche, Inc. | 1979-10-26 | 94 | 0 |
| K791206 | HCG RIA PREGNANCY TEST | Hoffmann-La Roche, Inc. | 1979-07-30 | 31 | 0 |
| K790655 | ABUSCREEN RIA FOR PHENCYCLIDINE | Hoffmann-La Roche, Inc. | 1979-06-15 | 71 | 0 |
| K790485 | AMYLOCHROME STAT SEPARATOR, TEST | Hoffmann-La Roche, Inc. | 1979-05-03 | 52 | 0 |
| K790357 | CPK-CS | Hoffmann-La Roche, Inc. | 1979-04-04 | 40 | 0 |
| K790267 | SENSI-TEX | Hoffmann-La Roche, Inc. | 1979-03-21 | 43 | 0 |
| K781236 | ENTEROTUBE II | Hoffmann-La Roche, Inc. | 1978-08-31 | 42 | 0 |
| K780428 | ROCHE TSH RIA | Hoffmann-La Roche, Inc. | 1978-03-30 | 13 | 0 |
| K771623 | T3 RIA | Hoffmann-La Roche, Inc. | 1977-09-20 | 26 | 0 |
| K770467 | IN VITRO DIAGNOSTIC TEST | Hoffmann-La Roche, Inc. | 1977-04-27 | 48 | 0 |
| K760089 | TEST, IN-VITRO DIAGNOSTIC | Hoffmann-La Roche, Inc. | 1976-07-20 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda